Very interesting data with the combo of aMVAC + pembro as neoadjuvant therapy for muscle invasive bladder cancer with histology subtypes/variants showing excellent path CR approaching 60% with no safety/feasibility concern (17 patients in a single center). 

Authors provided an update from NIAGARA phase 3 trial showing that perioperative durvalumab added to neoadjuvant Gem/Cis significantly prolonged EFS and OS vs neoadjuvant Gem/Cis alone. In an exploratory post hoc analyses, durvalumab appeared to prolong EFS and OS in both patient subsets with and without pathologic complete response to the neoadjuvant therapy phase. Immune related AEs were consistent with the known durvalumab profile and mostly low grade. 

Dr. Matthew Galsky shared comments on the recent efficacy outcomes updates (GU ASCO '25) regarding patients with muscle invasive bladder cancer enrolled in CheckMate 274 phase 3 trial, including specific patient subsets, as well as practical challenges and considerations in translating the trial findings into clinical practice.

EV+ pembrolizumab continues to show superior efficacy vs platinum based chemotherapy in a broad population (across patient subsets) consistent with the primary analysis. Data confirm durable efficacy with no new toxicity signal, further supporting this combo as the preferred standard of care 1L therapy in patients with advanced/metastatic urothelial carcinoma

In the TROPiCS04 phase 3 trial, presented by Dr. Petros Grivas et al. at ESMO-ASIA in December and recently published in 'Annals of Oncology' (T Powles et al.), sacituzumab govitecan (SG) did not result in a significant prolongation in overall or progression-free survival compared with taxane or vinflunine in patients with heavily pretreated advanced/metastatic urothelial carcinoma. Of note, SG efficacy was demonstrated by a higher overall response rate (23% vs 14%), while early toxicity-related complications, e.g. febrile neutropenia, with SG may have impacted trial outcomes. As a result, SG indication was voluntarily withdrawn (prior accelerated FDA approval based on TROPHY-U01, cohort 1, phase 2 trial data). The role of primary prophylaxis with G-CSF (to reduce febrile neutropenia risk) is critical if SG is used in this population.